Evaluation of a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA to the Community Colorectal Cancer Screening Program

NCT05638243 | Unknown

• 1 other identifier: METHOD-3
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence rate and mortality of colorectal cancer are increasing year by year. Most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. Thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. However, due to poor compliance with colonoscopy and the lack of efficient and convenient early screening methods, it is difficult to screen for colorectal cancer in China. According to the data from Shanghai Xuhui District Center for Disease Control and Prevention, the proportion of colonoscopies in high-risk groups for colorectal cancer is less than 18%. This project plans to use the latest colorectal cancer screening technology, namely, 5hmC detection in peripheral blood and DNA methylation detection in feces, for those who are positive in the colorectal cancer incidence risk questionnaire or fecal occult blood in Xuhui District, Shanghai. It is strongly recommended that subjects with positive screening should undergo colonoscopy, to effectively improve the rate of colonoscopy and the early diagnosis rate of colorectal cancer. At the same time, to explore the screening efficiency of the early diagnosis model of 5hmC cancer.

Conditions

Colorectal Cancer; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (3)

• Proportion of subjects receiving colonoscopy

  Proportion of subjects receiving colonoscopy

  Three years

• Proportion of subjects suffering early colorectal cancer

  Proportion of stageⅠcancer in total colorectal cancer

  Three years

• Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

  Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

  Three years

Study Arms (1)

High-risk residents

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Residents of Xuhui District, Shanghai, who are initially screened as high-risk for colorectal cancer by Shanghai Xuhui District Center for Disease Control and Prevention, and do not receive a colonoscopy. People who are willing to accept the screening program.

You may qualify if:

• Age ≥ 50 years old and\<75 years old;
• The initial screening was positive (fecal occult blood or colorectal cancer risk questionnaire was positive)； ③ Receive sample collection; ④ Sign the informed consent form.

You may not qualify if:

• ① History of colorectal cancer, colorectal adenoma, and treatment;
• Enteroscopy was performed after the initial screening was positive; ③ The subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Community Health Centers in Xuhui District

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jianmin Xu, M.D.， PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donghao Xu, M.D.

CONTACT

+86 17621317456; xdh1225@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Colorectal Surgery

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 6, 2022
• Study Start: August 20, 2022
• Primary Completion: February 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 6, 2022

Record last verified: 2022-11

Locations

CN (1)